Menzies Institute for Medical Research, University of Tasmania, Hobart, Tasmania, Australia.
School of Public Health and Preventive Medicine, Monash University, Alfred Hospital, Melbourne, Victoria, Australia.
JAMA. 2024 Jun 18;331(23):1997-2006. doi: 10.1001/jama.2024.6063.
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.
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.
Participants were randomized to 2 g/d of krill oil (n = 130) or matching placebo (n = 132) for 24 weeks.
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.
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).
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.
Australian New Zealand Clinical Trials Registry Identifier: ACTRN12616000726459; Universal Trial Number: U1111-1181-7087.
膝骨关节炎使人致残,目前有效的治疗方法寥寥无几。初步证据表明,磷虾油补充剂可改善膝关节疼痛,但对膝骨关节炎的疗效仍不清楚。
评估磷虾油补充剂与安慰剂相比,对有明显膝关节疼痛和关节积液-滑膜炎的膝骨关节炎患者膝关节疼痛的疗效。
设计、地点和参与者: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。2016 年 12 月至 2019 年 6 月期间,招募了磁共振成像显示有临床膝骨关节炎、明显膝关节疼痛和关节积液-滑膜炎的患者参加研究;最终随访于 2020 年 2 月 7 日进行。
参与者被随机分配每天服用 2 g 磷虾油(n = 130)或匹配的安慰剂(n = 132),共 24 周。
主要结局是 24 周时视觉模拟量表(VAS)评分(范围,0-100;0 表示疼痛最小;最小临床重要改善 = 15)的膝关节疼痛变化。
在 262 名随机分组的参与者中(平均年龄 61.6 [9.6]岁;53%为女性),222 名(85%)完成了试验。与安慰剂相比,磷虾油并未改善膝关节疼痛(VAS 评分平均变化,-19.9 [磷虾油] vs -20.2 [安慰剂];组间平均差异,-0.3;95%CI,-6.9 至 6.4)。24 周时,磷虾油组有 51%(67/130)和安慰剂组有 54%(71/132)报告发生 1 次或多次不良事件。最常见的不良事件是肌肉骨骼和结缔组织疾病,在磷虾油组发生 32 次,在安慰剂组发生 42 次,包括膝关节疼痛(磷虾油组 10 例,安慰剂组 9 例)、下肢疼痛(磷虾油组 1 例,安慰剂组 5 例)和髋关节疼痛(磷虾油组 3 例,安慰剂组 2 例)。
在磁共振成像显示有明显膝关节疼痛和关节积液-滑膜炎的膝骨关节炎患者中,与安慰剂相比,每天服用 2 g 磷虾油补充剂并不能在 24 周时改善膝关节疼痛。这些发现不支持磷虾油用于治疗该人群的膝关节疼痛。
澳大利亚和新西兰临床试验注册中心标识符:ACTRN12616000726459;通用试验编号:U1111-1181-7087。