Bromelain as an adjunctive treatment for moderate-to-severe osteoarthritis of the knee: a randomized placebo-controlled pilot study
Bromelain as an adjunctive treatment for moderate-to-severe osteoarthritis of the knee: a randomized placebo-controlled pilot study
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DOI：
10.1093/qjmed/hcl118
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发表时间：
2006-12-01
影响因子：
13.3
通讯作者：
Bundy, R.
中科院分区：
文献类型：
--
作者：
Brien, S.;Lewith, G.;Bundy, R.
背景：膝关节骨性关节炎（OA）是最常见的关节疾病。以前的研究表明，菠萝蛋白酶，菠萝提取物，可能是一个更安全的替代/预防治疗膝关节OA比目前的传统treatment.Aim：为了评估菠萝蛋白酶治疗OA的knee.Design的疗效：随机，双盲安慰剂对照试验。确诊为中度至重度膝关节OA的受试者（n=47）随机接受为期12周的菠萝蛋白酶800 mg/天或安慰剂治疗，随访4周。每月分别在WOMAC和SF 36问卷中报告膝关节（疼痛、僵硬和功能）和生活质量症状。还记录了不良事件。主要结局指标为第12周治疗结束时WOMAC总分较基线的变化。纵向模型被用来评估outcome.Results：31例患者完成了试验（14菠萝蛋白酶，17安慰剂）。两组间的主要结局（系数11.16，p=0.27，95%CI-8.86至31.18）、WOMAC子量表或SF 36均无统计学显著性差异。两个治疗组均仅在WOMAC残疾子量表中显示出临床相关改善。不良事件一般是轻度的nature.Discussion：这项研究表明，菠萝蛋白酶是不是有效的中重度OA的连续治疗，但其局限性支持需要进行后续研究。
Background: Osteoarthritis (OA) of the knee is the most prevalent joint disorder. Previous studies suggest that bromelain, a pineapple extract, may be a safer alternative/adjunctive treatment for knee OA than current conventional treatment.Aim: To assess the efficacy of bromelain in treating OA of the knee.Design: Randomized, double-blind placebo-controlled trial.Methods: Subjects (n=47) with a confirmed diagnosis of moderate to severe knee OA were randomized to 12 weeks of bromelain 800 mg/day or placebo, with a 4-week follow-up. Knee (pain, stiffness and function) and quality-of-life symptoms were reported monthly in the WOMAC and SF36 questionnaires, respectively. Adverse events were also recorded. The primary outcome measure was the change in total WOMAC score from baseline to the end of treatment at week 12. Longitudinal models were used to evaluate outcome.Results: Thirty-one patients completed the trial (14 bromelain, 17 placebo). No statistically significant differences were observed between groups for the primary outcome (coefficient 11.16, p=0.27, 95%CI-8.86 to 31.18), nor the WOMAC subscales or SF36. Both treatment groups showed clinically relevant improvement in the WOMAC disability subscale only. Adverse events were generally mild in nature.Discussion: This study suggests that bromelain is not efficacious as an adjunctive treatment of moderate to severe OA, but its limitations support the need for a follow-up study.