JAMA:磷虾油治疗膝关节骨性关节炎的随机临床试验

2024-05-24 来源:JAMA

本文由小咖机器人翻译整理

期刊来源:JAMA

原文链接:https://doi.org/10.1001/jama.2024.6063

摘要内容如下:

重要性

膝关节骨性关节炎是致残性的,很少有有效的治疗方法。初步证据表明,补充磷虾油可改善膝关节疼痛,但对膝骨关节炎的影响尚不清楚。

目的

与安慰剂相比,评估补充磷虾油对患有明显膝关节疼痛和渗出性滑膜炎的膝骨关节炎患者膝关节疼痛的疗效。

设计、设置和参与者

在澳大利亚5个城市进行的多中心、随机、双盲、安慰剂对照临床试验。从2016年12月至2019年6月,入组患有临床膝骨关节炎、显著膝关节疼痛和磁共振成像渗出性滑膜炎的参与者。最后一次随访于2020年2月7日进行。

干预措施

参与者被随机分配到2g/d的磷虾油(n=130)或匹配的安慰剂(n=132),为期24周。

主要成果和措施

主要转归是通过视觉模拟评分评估的膝关节疼痛变化(范围0-100;0表示最小疼痛;最小临床重要改善=15)超过24周。

结果

262名参与者被随机分组(平均年龄61.6[SD,9.6]岁;53%为女性),222人(85%)完成了试验。与安慰剂相比,磷虾油没有改善膝关节疼痛(VAS评分的平均变化,-19.9[磷虾油]vs-20.2[安慰剂];组间平均差,-0.3;95%CI,-6.9至6.4)超过24周。51%的磷虾油组(67/130)和54%的安慰剂组(71/132)报告了一个或多个不良事件。最常见的不良事件是肌肉骨骼和结缔组织疾病,磷虾油组出现32次,安慰剂组出现42次,包括膝关节疼痛(磷虾油组n=10;安慰剂组n=9),下肢疼痛(磷虾油组n=1;安慰剂组n=5)和髋部疼痛(磷虾油组n=3;n=2(安慰剂组)。

结论和相关性

在磁共振成像显示有明显膝关节疼痛和渗出性滑膜炎的膝骨关节炎患者中,与安慰剂相比,每日补充2g/d的磷虾油在24周内并未改善膝关节疼痛。这些发现并不支持磷虾油用于治疗这一人群的膝关节疼痛。

试用注册

澳大利亚新西兰临床试验注册标识符:ACTRN12616000726459;通用试用号:U1111-1181-7087。

英文原文如下:

Abstracts

Importance  Knee osteoarthritis is disabling, with few effective treatments. Preliminary evidence suggested that krill oil supplementation improved knee pain, but effects on knee osteoarthritis remain unclear.

Objective  To evaluate efficacy of krill oil supplementation, compared with placebo, on knee pain in people with knee osteoarthritis who have significant knee pain and effusion-synovitis.

Design, Setting, and Participants  Multicenter, randomized, double-blind, placebo-controlled clinical trial in 5 Australian cities. Participants with clinical knee osteoarthritis, significant knee pain, and effusion-synovitis on magnetic resonance imaging were enrolled from December 2016 to June 2019; final follow-up occurred on February 7, 2020.

Interventions  Participants were randomized to 2 g/d of krill oil (n = 130) or matching placebo (n = 132) for 24 weeks.

Main Outcomes and Measures  The primary outcome was change in knee pain as assessed by visual analog scale (range, 0-100; 0 indicating least pain; minimum clinically important improvement = 15) over 24 weeks.

Results  Of 262 participants randomized (mean age, 61.6 [SD, 9.6] years; 53% women), 222 (85%) completed the trial. Krill oil did not improve knee pain compared with placebo (mean change in VAS score, -19.9 [krill oil] vs -20.2 [placebo]; between-group mean difference, -0.3; 95% CI, -6.9 to 6.4) over 24 weeks. One or more adverse events was reported by 51% in the krill oil group (67/130) and by 54% in the placebo group (71/132). The most common adverse events were musculoskeletal and connective tissue disorders, which occurred 32 times in the krill oil group and 42 times in the placebo group, including knee pain (n = 10 with krill oil; n = 9 with placebo), lower extremity pain (n = 1 with krill oil; n = 5 with placebo), and hip pain (n = 3 with krill oil; n = 2 with placebo).

Conclusions and Relevance  Among people with knee osteoarthritis who have significant knee pain and effusion-synovitis on magnetic resonance imaging, 2 g/d of daily krill oil supplementation did not improve knee pain over 24 weeks compared with placebo. These findings do not support krill oil for treating knee pain in this population.

Trial Registration  Australian New Zealand Clinical Trials Registry Identifier: ACTRN12616000726459; Universal Trial Number: U1111-1181-7087.

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