Oben Julius, Enonchong Ebangha, Kothari Shil, Chambliss Walter, Garrison Robert, Dolnick Deanne
Laboratory of Nutrition & Nutritional Biochemistry, Department of Biochemistry, University of Yaounde I, Cameroon.
Nutr J. 2009 Aug 14;8:38. doi: 10.1186/1475-2891-8-38.
The objective of this clinical study was to assess the potential benefit of a dietary supplement, NP 06-1, on joint health in overweight and normal weight adults diagnosed with osteoarthritis.
An 8-week placebo-controlled, randomized, double-blind study was conducted with four groups comparing the effects of NP 06-1 to placebo on overweight and normal weight subjects diagnosed with primary osteoarthritis of the knee. NP 06-1 (a combination of two botanical extracts; Phellodendron amurense bark and Citrus sinensis peel) or matching placebo were given in a dose of two capsules (370 mg each) twice daily. The outcome measures were the Lequesne Algofunctional Index (LAI) for joint pain and movement as well as biomarkers of inflammation (C-reactive protein [CRP] and erythrocyte sedimentation rate [ESR]).
Eighty (80) subjects were enrolled and 45 subjects completed the study. No serious adverse events were reported. The mean total LAI scores at baseline for the four groups ranged from 11.4 to 12.4 (SD 1.2 to 2.4). Treatment for 8 weeks resulted in a statistical improvement in the LAI score in the overweight treatment group compared to placebo (6.3 +/- 2.3 vs 11.8 +/- 1.5; p < 0.0001). At 8 weeks, a similar result was observed in the normal weight groups (7.7 +/- 1.4 vs 9.9 +/- 0.9; p < 0.0001). There was a reduction in CRP levels with treatment in the overweight treatment group at 8 weeks (-0.62 +/- 0.2; 49%) compared to baseline (p < 0.001) and to placebo (p < 0.001). For the normal weight participants, there were significant reductions in CRP compared to baseline, but not to the matched placebo group. Both overweight and normal weight treatment groups lost a significant amount of weight compared to their placebo groups. The overweight treatment group lost an average of 5% body weight after 8 weeks. There was no significant change in ESR in any of the groups.
In this pilot study, NP 06-1 had beneficial effects on symptoms of osteoarthritis of the knee as measured using LAI scores and had anti-inflammatory effects as measured using CRP. Administration of NP 06-1 was also associated with weight loss, which may have been a contributing factor to the other benefits.
本临床研究的目的是评估一种膳食补充剂NP 06 - 1对被诊断为骨关节炎的超重和正常体重成年人关节健康的潜在益处。
进行了一项为期8周的安慰剂对照、随机、双盲研究，分为四组，比较NP 06 - 1与安慰剂对被诊断为膝关节原发性骨关节炎的超重和正常体重受试者的影响。NP 06 - 1（两种植物提取物的组合；黄柏树皮和橙子皮）或匹配的安慰剂以每日两次、每次两粒胶囊（每粒370毫克）的剂量给药。观察指标为关节疼痛和活动的Lequesne功能指数（LAI）以及炎症生物标志物（C反应蛋白[CRP]和红细胞沉降率[ESR]）。
招募了80名受试者，45名受试者完成了研究。未报告严重不良事件。四组在基线时的平均总LAI评分在11.4至12.4之间（标准差1.2至2.4）。与安慰剂相比，超重治疗组治疗8周后LAI评分有统计学意义的改善（6.3±2.3对11.8±1.5；p<0.0001）。在8周时，正常体重组也观察到类似结果（7.7±1.4对9.9±0.9；p<0.0001）。与基线相比（p<0.001）以及与安慰剂相比（p<0.001），超重治疗组在8周治疗后CRP水平降低（-0.62±0.2；降低49%）。对于正常体重参与者，与基线相比CRP有显著降低，但与匹配的安慰剂组相比无显著差异。与各自的安慰剂组相比，超重和正常体重治疗组均有显著体重减轻。超重治疗组在8周后平均体重减轻了5%。任何组的ESR均无显著变化。
在这项初步研究中，NP 06 - 1使用LAI评分测量时对膝关节骨关节炎症状有有益影响，使用CRP测量时有抗炎作用。服用NP 06 - 1还与体重减轻有关，这可能是其他益处的一个促成因素。
