Department of Orthopedics, Assaf Harofeh Medical Center, Zerifin, Israel.
BMC Complement Altern Med. 2011 Jun 27;11:50. doi: 10.1186/1472-6882-11-50.
Patients with osteoarthritis (OA) take a variety of health supplements in an attempt to reduce pain and improve function. The aim of this study was to determine the efficacy of methylsulfonylmethane (MSM) in treating patients with knee OA.
This study was a prospective, randomized, double-blind, controlled clinical trial. Forty nine men and women 45-90 (mean 68 ± SD 7.3) years of age with knee OA according to the American College of Rheumatology clinical criteria for OA of the knee and with radiographic confirmed knee OA were enrolled in the study and randomly assigned into 2 groups: One received MSM in doses of 1.125 grams 3 times daily for 12 weeks and the other received a placebo in the same dosing frequency. The primary outcomes were the WOMAC Osteoarthritis Index for pain, stiffness and physical function, the Aggregated Locomotor Function (ALF) test that evaluates each patient's physical function, the SF-36 quality of life health survey and the visual-analogue-scale (VAS) for pain. The secondary outcomes were Knee Society Clinical Rating System for Knee Score (KSKS) and Function Score (KSFS). Patients were assessed at baseline, 6 weeks and 12 weeks. All continuous variables were tested by the Kolmogorov-Smirnov test for Normal distribution. Changes within the groups and differences between the groups were calculated by repeated measures of analysis (ANOVA) with one nested variable.
There were significant differences between treatment groups over time in WOMAC physical function (14.6 mm [CI: 4.3, 25.0]; p = 0.04) and in WOMAC total score (15.0 mm [CI: 5.1, 24.9]; p = 0.03). Treatment groups did not differ significantly in WOMAC pain (12.4 mm [CI: 0.0, 24.8]); p = 0.08) or WOMAC stiffness (27.2 mm [CI: 8.2, 46.2]; p = 0.08). There was a non-significant difference in SF-36 total score between treatment groups (11.6 [CI: 1.0, 22.1]; p = 0.54). A significant difference was found between groups in VAS for pain (0.7 s [CI: -0.9, 2.4]; p = 0.05). Secondary outcomes showed non-significant differences between the two groups.
Patients with OA of the knee taking MSM for 12 weeks showed an improvement in pain and physical function. These improvements, however, are small and it is yet to be determined if they are of clinical significance.
ClinicalTrials.gov: NCT01188213.
骨关节炎(OA)患者服用各种保健品,试图减轻疼痛并改善功能。本研究旨在确定甲磺酰甲烷(MSM)治疗膝骨关节炎患者的疗效。
这是一项前瞻性、随机、双盲、对照临床试验。49 名年龄在 45-90 岁(平均 68 ± 7.3 岁)的男性和女性,根据美国风湿病学会膝骨关节炎临床标准和影像学证实的膝骨关节炎,被纳入研究并随机分为 2 组:一组接受 MSM,剂量为 1.125 克,每日 3 次,持续 12 周;另一组接受相同剂量的安慰剂。主要结局指标是 WOMAC 骨关节炎指数的疼痛、僵硬和身体功能,评估每位患者身体功能的综合运动功能(ALF)试验,SF-36 生活质量健康调查和疼痛视觉模拟量表(VAS)。次要结局指标为膝关节学会临床评分系统的膝关节评分(KSKS)和功能评分(KSFS)。患者在基线、6 周和 12 周进行评估。所有连续变量均通过 Kolmogorov-Smirnov 检验进行正态分布检验。通过重复测量分析(ANOVA)计算组内和组间的变化,其中包含一个嵌套变量。
治疗组在 WOMAC 身体功能(14.6mm [CI:4.3,25.0];p=0.04)和 WOMAC 总分(15.0mm [CI:5.1,24.9];p=0.03)方面存在显著的时间差异。治疗组在 WOMAC 疼痛(12.4mm [CI:0.0,24.8])或 WOMAC 僵硬(27.2mm [CI:8.2,46.2])方面差异无统计学意义。治疗组在 SF-36 总分方面差异无统计学意义(11.6 [CI:1.0,22.1];p=0.54)。两组间疼痛 VAS 存在显著差异(0.7s [CI:-0.9,2.4];p=0.05)。次要结局显示两组间差异无统计学意义。
接受 MSM 治疗 12 周的膝骨关节炎患者疼痛和身体功能得到改善。然而,这些改善很小,目前尚不确定它们是否具有临床意义。
ClinicalTrials.gov:NCT01188213。