Majeed Anju, Majeed Shaheen, Satish G, Manjunatha R, Rabbani Shaikh Nawazish, Patil Neelanagowda V P, Mundkur Lakshmi
Sami-Sabinsa Group Limited, Peenya Industrial Area Bangalore, Bangalore, Karnataka, India.
Sabinsa Corporation, East Windsor, NJ, United States.
Front Pharmacol. 2024 Jul 18;15:1428440. doi: 10.3389/fphar.2024.1428440. eCollection 2024.
Boswellin Super is a standardized extract of Roxb gum resin, standardized to contain 30% 3-acetyl-11-keto-β-boswellic acid along with other β-boswellic acids (BSE). A randomized, double-blind, placebo-controlled clinical trial was conducted at two doses of BSE to understand its safety and efficacy in supporting joint health and improving mobility and symptoms of osteoarthritis (OA) of the knee.
Based on the inclusion/exclusion criteria, 105 newly diagnosed participants with degenerative hypertrophy OA were recruited and randomized into Placebo, BSE-150 mg or BSE-300 mg (n = 35 in each group) to receive either 150 mg or 300 mg BSE or a placebo tablet twice a day for 90 days. All the participants were evaluated for pain and physical function using the standard tools including the Visual Analog Scale (VAS), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Lequesne Functional Index (LFI), EuroQol- 5 Dimension (EQ-5D) quality of life, 6-min walk test at day 0, days 5, 30, 60 and 90 of treatment. Additionally, the circulating levels of inflammatory biomarkers, tumor necrosis factor-α (TNFα), high-sensitive C-reactive protein (hs-CRP), and interleukin-6 (IL-6) were evaluated. Safety was evaluated by blood biochemical, hematological analysis, urinary analyses and by monitoring adverse events throughout the study.
Ninety-eight subjects completed the study. Improvements in pain scores were observed as early as 5 days after the start of the supplement in the BSE-150 and BSE-300 groups. By 90 days, the VAS pain score reduced by 45.3% and 61.9%, WOMAC- total score improved by 68.5% and 73.6% in the BSE-150 and BSE-300 groups respectively. WOMAC pain (70.2%, 73.9%, WOMAC stiffness (65.6%,68.9%), WOMAC function (68.8%,74.2%), LFI severity (50%,53.3%), decreased and EQ5D (56.9%, 62.9%) and distance walked in 6 minutes (21.2%, 21.9%) improved in the BSE-150 and BSE-300 groups in 90 days. Further, the levels of TNFα, hs-CRP, and IL-6 were found to decrease in the serum in BSE-supplemented participants. No significant adverse events were recorded during the study.
The study confirms that can be used as a safe and effective supplement to support joint health and mobility in the management of osteoarthritis.
https://ctri.nic.in/Clinicaltrials/pmaindet2.php?EncHid=NzU2Nzc=&Enc=&userName=CTRI, identifier CTRI/2022/11/047397.
博斯韦林超级胶囊是一种经过标准化提取的没药树脂提取物，其标准化成分包含30%的3 - 乙酰 - 11 - 酮 - β - 乳香酸以及其他β - 乳香酸（BSE）。开展了一项随机、双盲、安慰剂对照的临床试验，使用两种剂量的BSE，以了解其在支持关节健康以及改善膝关节骨关节炎（OA）的活动能力和症状方面的安全性和有效性。
根据纳入/排除标准，招募了105名新诊断的退行性肥大性OA患者，并将其随机分为安慰剂组、150毫克BSE组或300毫克BSE组（每组35人），每天服用两次150毫克或300毫克BSE或安慰剂片，持续90天。使用包括视觉模拟量表（VAS）、西安大略和麦克马斯特大学骨关节炎指数（WOMAC）、勒凯斯内功能指数（LFI）、欧洲五维健康量表（EQ - 5D）生活质量、治疗第0天、第5天、第30天、第60天和第90天的6分钟步行试验等标准工具，对所有参与者的疼痛和身体功能进行评估。此外，还评估了炎症生物标志物肿瘤坏死因子 - α（TNFα）、高敏C反应蛋白（hs - CRP）和白细胞介素 - 6（IL - 6）的循环水平。通过血液生化、血液学分析、尿液分析以及在整个研究过程中监测不良事件来评估安全性。
98名受试者完成了研究。在BSE - 150和BSE - 300组中，早在补充剂开始服用5天后就观察到疼痛评分有所改善。到90天时，BSE - 150组和BSE - 300组的VAS疼痛评分分别降低了45.3%和61.9%，WOMAC总分分别提高了68.5%和73.6%。90天时，BSE - 150组和BSE - 300组的WOMAC疼痛（分别为70.2%、73.9%）、WOMAC僵硬（分别为65.6%、68.9%）、WOMAC功能（分别为68.8%、74.2%）、LFI严重程度（分别为50%、53.3%）下降，EQ5D（分别为56.9%、62.9%）和6分钟步行距离（分别为21.2%、21.9%）得到改善。此外，补充BSE的参与者血清中TNFα、hs - CRP和IL - 6的水平有所下降。研究期间未记录到显著的不良事件。
该研究证实，[原文此处似乎有缺失内容]可作为一种安全有效的补充剂，用于在骨关节炎管理中支持关节健康和活动能力。
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