■膝关节骨性关节炎致残,很少有有效的治疗方法。初步证据表明,补充磷虾油可以改善膝关节疼痛,但对膝骨关节炎的影响仍不清楚。
■为了评估补充磷虾油的功效,与安慰剂相比,膝关节骨性关节炎患者的膝关节疼痛,有明显的膝关节疼痛和渗出性滑膜炎。
■多中心,随机化,双盲,澳大利亚5个城市的安慰剂对照临床试验。临床膝关节骨关节炎的参与者,严重的膝盖疼痛,2016年12月至2019年6月纳入磁共振成像的积液-滑膜炎;最后一次随访发生在2020年2月7日.
■参与者被随机分配给2g/d磷虾油(n=130)或匹配的安慰剂(n=132),持续24周。
■主要结果是通过视觉模拟量表评估的膝关节疼痛变化(范围,0-100;0表示疼痛最小;最小临床重要改善=15)超过24周。
■随机分组的262名参与者(平均年龄,61.6[SD,9.6]岁;53%是女性),222人(85%)完成试验。与安慰剂相比,磷虾油并未改善膝关节疼痛(VAS评分的平均变化,-19.9[磷虾油]vs-20.2[安慰剂];组间平均差异,-0.3;95%CI,-6.9至6.4)超过24周。在磷虾油组(67/130)和安慰剂组(71/132)中报告了一个或多个不良事件的51%。最常见的不良事件是肌肉骨骼和结缔组织疾病,磷虾油组发生32次,安慰剂组发生42次,包括膝关节疼痛(磷虾油n=10;安慰剂n=9),下肢疼痛(磷虾油n=1;安慰剂n=5),和髋部疼痛(磷虾油n=3;安慰剂n=2)。
■在磁共振成像上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,每天2g/d的磷虾油补充剂在24周内并未改善膝关节疼痛。这些发现不支持磷虾油治疗该人群的膝关节疼痛。
■澳大利亚新西兰临床试验注册标识符:ACTRN12616000726459;通用试验编号:U1111-1181-7087。
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.
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.