Nakasone Yasushi, Watabe Kazunori, Watanabe Keita, Tomonaga Akihito, Nagaoka Isao, Yamamoto Tetsuro, Yamaguchi Hideyo
Kenkoukazoku, Inc., Kagoshima 892-0848;
Exp Ther Med. 2011 Sep;2(5):893-899. doi: 10.3892/etm.2011.298. Epub 2011 Jun 27.
In the present study, we aimed to investigate the potential effect of a glucosamine (1,200 mg/day)-based dietary supplement combined with chondroitin sulfate and three antioxidant micronutrients, namely methylsulfonylmethane, guava leaf extract, and vitamin D (test supplement) on osteoarthritis (OA) of the knee. A 16-week, randomized, double-blinded, placebo-controlled trial was conducted involving 32 subjects with symptomatic knee OA. Clinical outcomes were measured using the Japanese Knee Osteoarthritis Measure (JKOM) for symptoms and a study diary-based visual analog scale (diary VAS) for pain at baseline and at weeks 4, 8, 12 and 16 during the 16-week intervention period. Furthermore, biomarkers for cartilage type II collagen degradation (C2C) and synovitis hyaluronan (HA) were measured. As compared with the baseline, the JKOM pain subscale was significantly improved at all of the four assessment time points in the test group, but was not at any time point in the placebo group. On the other hand, all of the four symptom subscales and the aggregated total symptoms were significantly improved in the two groups at one or more time points. However, all of these clinical improvements were greater in extent in the test group than in the placebo group, and there were significant differences between groups in the magnitude of changes from baseline for one subscale 'general activities' and the aggregated total symptoms at week 8 (P<0.05). The results of efficacy assessments with the diary VAS showed that all of the three pain subscales were significantly improved only in the test group at almost all the time points. Moreover, serum levels of C2C and HA were decreased by 10 and 25%, respectively, at week 16 in the test group, albeit not statistically significant, without any detectable changes in the placebo group. In conclusion, although the results obtained in this study were not conclusive, the tested glucosamine-based combination supplement is likely to have a beneficial effect on pain and other symptoms associated with knee OA.
在本研究中,我们旨在探究一种以氨基葡萄糖(每日1200毫克)为基础、联合硫酸软骨素及三种抗氧化微量营养素(即二甲基砜、番石榴叶提取物和维生素D,试验补充剂)的膳食补充剂对膝关节骨关节炎(OA)的潜在影响。我们进行了一项为期16周的随机、双盲、安慰剂对照试验,纳入了32名有症状的膝关节OA患者。在16周的干预期内,于基线时以及第4、8、12和16周,使用日本膝关节骨关节炎测量表(JKOM)评估症状,并使用基于研究日记的视觉模拟量表(日记VAS)评估疼痛,以此来衡量临床结果。此外,还测量了软骨II型胶原降解(C2C)和滑膜炎透明质酸(HA)的生物标志物。与基线相比,试验组在所有四个评估时间点的JKOM疼痛子量表均有显著改善,而安慰剂组在任何时间点均未改善。另一方面,两组在一个或多个时间点的所有四个症状子量表以及汇总的总症状均有显著改善。然而,试验组的所有这些临床改善程度均大于安慰剂组,并且在第8周时,“一般活动”这一症状子量表以及汇总的总症状从基线变化的幅度在两组间存在显著差异(P<0.05)。日记VAS的疗效评估结果显示,几乎在所有时间点,仅试验组的所有三个疼痛子量表均有显著改善。此外,试验组在第16周时血清C2C和HA水平分别下降了10%和25%,尽管无统计学意义,而安慰剂组未检测到任何变化。总之,尽管本研究所得结果尚无定论,但所测试的基于氨基葡萄糖的联合补充剂可能对与膝关节OA相关的疼痛和其他症状具有有益作用。