Wolsko Peter M, Eisenberg David M, Simon Lee S, Davis Roger B, Walleczek Jan, Mayo-Smith Michael, Kaptchuk Ted J, Phillips Russell S
Division for Research and Education, Harvard Medical School, Boston, MA, USA.
Altern Ther Health Med. 2004 Mar-Apr;10(2):36-43.
Outpatient clinical studies of magnet therapy, a complementary therapy commonly used to treat osteoarthritis (OA), have been limited by the absence of a credible placebo control.
Our objective was to assess the feasibility and promise of studying static magnetic therapy for knee OA and determine the ability of a new placebo-magnet device to provide concealment of group assignment.
Randomized, double-blind, placebo-controlled clinical trial.
Academic teaching hospital in Boston.
We enrolled 29 subjects with idiopathic or post-traumatic OA of the knee.
Subjects received either high-strength magnetic (active) or placebo-magnetic (placebo) knee sleeve treatment for 4 hours in a monitored setting and self-treatment 6 hours daily for 6 weeks.
Primary outcomes were change in knee pain as measured by the WOMAC Osteoarthritis Index Pain Subscale at 6 weeks and extent of group concealment at study end.
At 4 hours, VAS pain scores (+/- SE) on a 5-item scale (0-500, 500 worst) decreased 79 +/- 18 mm in the active group and 10 +/- 21 mm in the placebo group (P < 0.05). There were no significant differences in any primary or secondary measure of efficacy between the treatment groups at 6 weeks. Despite widespread testing for magnetic properties, at study end, 69% of the active group and 77% of the placebo group (P > 0.2) believed that they had been assigned to the active treatment group.
Despite our small sample size, magnets showed statistically significant efficacy compared to placebo after 4 hours under rigorously controlled conditions. The sustained efficacy of magnetic therapy for knee osteoarthritis could be assessed in an adequately powered trial utilizing an appropriate control such our new placebo-magnet device.
磁疗法作为一种常用于治疗骨关节炎（OA）的补充疗法，其门诊临床研究因缺乏可靠的安慰剂对照而受到限制。
我们的目的是评估研究静态磁疗对膝骨关节炎的可行性和前景，并确定一种新型安慰剂磁疗装置对分组进行隐匿的能力。
随机、双盲、安慰剂对照临床试验。
波士顿的一家学术教学医院。
我们招募了29名患有特发性或创伤后膝骨关节炎的受试者。
受试者在监测环境中接受高强度磁疗（活性组）或安慰剂磁疗（安慰剂组）膝部护具治疗4小时，然后每天自行治疗6小时，持续6周。
主要结局是通过WOMAC骨关节炎指数疼痛子量表在6周时测量的膝关节疼痛变化以及研究结束时的分组隐匿程度。
4小时时，在0至500（500为最差）的5级视觉模拟评分（VAS）疼痛评分（±标准误）中，活性组降低了79±18毫米，安慰剂组降低了10±21毫米（P<0.05）。6周时，治疗组之间在任何主要或次要疗效指标上均无显著差异。尽管对磁性进行了广泛测试，但在研究结束时，活性组69%的受试者和安慰剂组77%的受试者（P>0.2）认为他们被分配到了活性治疗组。
尽管我们的样本量较小，但在严格控制的条件下，磁疗在4小时后与安慰剂相比显示出统计学上显著的疗效。利用我们新型的安慰剂磁疗装置等合适的对照，在一项有足够样本量的试验中可以评估磁疗对膝骨关节炎的持续疗效。
