Tant Laure, Gillard Bruno, Appelboom Thierry
Division of Rheumatology and Physical Medicine, Erasme University Hospital, Brussels, Belgium.
Curr Ther Res Clin Exp. 2005 Nov;66(6):511-21. doi: 10.1016/j.curtheres.2005.12.009.
A series of studies has suggested some efficacy of glucosamine in arthrosis of the knee, but virtually no documentation exists regarding its effects on low back pain.
The primary objective of this study was to examine whether a 12-week course of a glucosamine complex (GC) could benefit patients having low back pain despite a course of noninvasive physical therapy. In addition, we sought to delineate the subgroup of responders.
This open-label, randomized, controlled study was conducted at the Division of Rheumatology and Physical Medicine, Erasme University Hospital, Brussels, Belgium. Male and female outpatients aged 40 to 80 years with low back pain (duration, ≥ 12 weeks; pain score on 10-cm visual analog scale [VAS] [0 = none to 10 = worst imaginable], ≥3 cm) despite noninvasive physical therapy (massage, stretching, heat application, and analgesics for ≥4 weeks) were included. Patients were randomly assigned to receive, in addition to conventional treatment (CT) (physical therapy plus analgesics/antiinflammatories), a GC (enriched with sulfonyl methane, silicon, and a botanical extract of Ribes nigrum) or CT alone (control) for 12 weeks. Pain at rest and on movement (effort) and early morning lumbar stiffness were measured every 4 weeks using the VAS. The primary end point was improvement in VAS score for pain at rest at 12 weeks. Two validated questionnaires were used to assess improvements in quality of life (QOL) (Oswestry Disability Questionnaire [ODQ] [10 items; scale: 0 = no disability to 60 = maximal disability] and Roland-Morris Disability Questionnaire [RMDQ] [24 items; scale: 0 = no disability to 24 = severe disability]). Responders were defined as patients who positively assessed the efficacy of the GC. At each visit, patients were also asked about possible adverse events.
Of 36 enrolled patients, 32 completed the study (18 men, 14 women; mean [SE] age, 64 [2] years; 17 in the GC group and 15 in the control group). Four patients were lost to follow-up. At week 4, changes from baseline VAS scores for pain at rest and lumbar stiffness were significantly greater in the GC group compared with the control group (P < 0.001 and P = 0.011, respectively). At week 4, QOL was found to be improved, as measured using the ODQ, in the GC group compared with the control group (P = 0.028), but the between-group difference as measured using the RMDQ was not significant. The improvements from baseline on the questionnaires were sustained over the 12-week period in the GC group (all, P < 0.001). Gastrointestinal adverse effects were reported by 1 GC-treated patient and 1 patient in the control group, but neither patient withdrew from the study. Of the 17 GC-treated patients, 9 considered themselves responders, but the profile of a responder could not be delineated.
In this study in patients with low back pain, analgesic effect and improvement in QOL were found with the use of GC. GC was well tolerated.
一系列研究表明氨基葡萄糖对膝关节骨关节炎有一定疗效，但几乎没有关于其对腰痛影响的文献记载。
本研究的主要目的是检验为期12周的氨基葡萄糖复合物（GC）疗程是否能使尽管接受了无创物理治疗但仍患有腰痛的患者受益。此外，我们试图确定有反应的亚组。
本开放标签、随机、对照研究在比利时布鲁塞尔伊拉斯谟大学医院风湿病与物理医学科进行。纳入年龄在40至80岁之间、尽管接受了无创物理治疗（按摩、拉伸、热敷和使用镇痛药≥4周）但仍患有腰痛（病程≥12周；在10厘米视觉模拟量表[VAS][0 = 无疼痛至10 = 难以想象的剧痛]上疼痛评分≥3厘米）的门诊男女患者。患者被随机分配，除接受常规治疗（CT）（物理治疗加镇痛药/抗炎药）外，一组接受GC（富含甲磺酰甲烷、硅和黑醋栗植物提取物），另一组仅接受CT（对照组），为期12周。每4周使用VAS测量静息和活动时（用力时）的疼痛以及清晨腰椎僵硬程度。主要终点是12周时静息疼痛的VAS评分改善情况。使用两份经过验证的问卷评估生活质量（QOL）的改善情况（奥斯威斯残疾问卷[ODQ][10项；评分范围：0 = 无残疾至60 = 最大残疾]和罗兰-莫里斯残疾问卷[RMDQ][24项；评分范围：0 = 无残疾至24 = 严重残疾]）。有反应者定义为对GC疗效给予肯定评价的患者。每次就诊时，还询问患者是否有可能的不良事件。
36名入组患者中，32名完成了研究（18名男性，14名女性；平均[标准差]年龄，64[2]岁；GC组17名，对照组15名）。4名患者失访。在第4周时，GC组静息疼痛和腰椎僵硬的VAS评分相对于基线的变化显著大于对照组（分别为P < 0.001和P = 0.011）。在第4周时，使用ODQ测量发现GC组的QOL相对于对照组有所改善（P = 0.028），但使用RMDQ测量的组间差异不显著。GC组在12周期间问卷相对于基线的改善情况持续存在（均为P < 0.001）。1名接受GC治疗的患者和1名对照组患者报告有胃肠道不良反应，但均未退出研究。在17名接受GC治疗的患者中，9名认为自己是有反应者，但无法确定有反应者的特征。
在本针对腰痛患者的研究中，使用GC发现有镇痛作用且生活质量得到改善。GC耐受性良好。
