Students Research Committee, School of Pharmacy and Pharmaceutical Sciences, Isfahan University of Medical Sciences, Isfahan, Iran.
Department of Rheumatology, School of Medicine, Isfahan University of Medical Sciences, Isfahan, Iran.
BMC Res Notes. 2023 Mar 4;16(1):28. doi: 10.1186/s13104-023-06291-5.
Pharmacological treatments of osteoarthritis (OA) have several side effects. Boswellia serrata resin (frankincense) is rich in boswellic acids that have antioxidant and anti-inflammatory effects; though, their oral bioavailability is low. The aim of this study was evaluation of the clinical effectiveness of frankincense extract in the treatment of knee OA. In a randomized double-blind placebo-controlled clinical trial, eligible patients with knee OA were randomly divided into two groups of drug (33 patients) and control (37 patients), to use oily solution of frankincense extract or placebo, respectively, on the involved knee three times daily for four weeks. WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index), VAS (visual analogue scale; for pain severity), and PGA (patient global assessment) scores were determined before and after intervention.
For all evaluated outcome variables, there was a significant decrease from baseline in both groups (P < 0.001 for all). Furthermore, the end-of-intervention values for all parameters were significantly lower in drug group than placebo group (P < 0.001 for all), showing more effectiveness of drug compared to placebo.
Topical oily solution containing enriched extract of boswellic acids could decrease pain severity and improve the function in patients with knee OA. Trial Registration Trial registration number: IRCT20150721023282N14. Trial registration date: September 20, 2020. The study was retrospectively registered in Iranian Registry of Clinical Trials (IRCT).
治疗骨关节炎(OA)的药物治疗有多种副作用。乳香树脂(乳香)富含具有抗氧化和抗炎作用的乳香酸;然而,其口服生物利用度较低。本研究旨在评估乳香提取物治疗膝骨关节炎的临床疗效。在一项随机、双盲、安慰剂对照的临床试验中,符合条件的膝骨关节炎患者被随机分为两组,药物组(33 例)和对照组(37 例),分别使用乳香提取物油性溶液或安慰剂,每天三次涂于受累膝关节,持续四周。在干预前后测定 WOMAC(西安大略和麦克马斯特大学骨关节炎指数)、VAS(视觉模拟量表;用于疼痛严重程度)和 PGA(患者总体评估)评分。
所有评估的结局变量在两组中均有显著下降(所有 P 值均<0.001)。此外,药物组在所有参数的干预结束时的值均明显低于安慰剂组(所有 P 值均<0.001),表明药物比安慰剂更有效。
含有富含乳香酸的浓缩提取物的油性溶液可降低膝骨关节炎患者的疼痛严重程度并改善其功能。试验注册试验注册号:IRCT20150721023282N14。试验注册日期:2020 年 9 月 20 日。该研究在伊朗临床试验注册中心(IRCT)进行了回顾性注册。