David R Mandel MD Inc, Mayfield Village, OH 44143, USA.
BMC Complement Altern Med. 2010 Jan 12;10:1. doi: 10.1186/1472-6882-10-1.
Lactic acid-producing bacteria (LAB) probiotics demonstrate immunomodulating and anti-inflammatory effects and the ability to lessen the symptoms of arthritis in both animals and humans. This randomized, double-blind, placebo-controlled, parallel-design, clinical pilot trial was conducted to evaluate the effects of the LAB probiotic preparation, Bacillus coagulans GBI-30, 6086, on symptoms and measures of functional capacity in patients with rheumatoid arthritis (RA) in combination with pharmacological anti-arthritic medications.
Forty-five adult men and women with symptoms of RA were randomly assigned to receive Bacillus coagulans GBI-30, 6086 or placebo once a day in a double-blind fashion for 60 days in addition to their standard anti-arthritic medications. Arthritis activity was evaluated by clinical examination, the American College of Rheumatology (ACR) criteria, the Stanford Health Assessment Questionnaire Disability Index (HAQ-DI), and laboratory tests for erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP).
Subjects who received Bacillus coagulans GBI-30, 6086 experienced borderline statistically significant improvement in the Patient Pain Assessment score (P = .052) and statistically significant improvement in Pain Scale (P = .046) vs placebo. Compared with placebo, Bacillus coagulans GBI-30, 6086 treatment resulted in greater improvement in patient global assessment and self-assessed disability; reduction in CRP; as well as the ability to walk 2 miles, reach, and participate in daily activities. There were no treatment-related adverse events reported throughout this study.
Results of this pilot study suggest that adjunctive treatment with Bacillus coagulans GBI-30, 6086 LAB probiotic appeared to be a safe and effective for patients suffering from RA. Because of the low study population size, larger trials are needed to verify these results.
ACTRN12609000435280.
产乳酸细菌（LAB）益生菌具有免疫调节和抗炎作用，并能减轻动物和人类关节炎的症状。这项随机、双盲、安慰剂对照、平行设计的临床初步试验旨在评估 LAB 益生菌制剂凝结芽孢杆菌 GBI-30,6086 与药物联合使用对类风湿关节炎（RA）患者症状和功能能力测量的影响。
45 名有 RA 症状的成年男女随机分为 3 组，分别接受凝结芽孢杆菌 GBI-30,6086 或安慰剂，每天一次，双盲，持续 60 天，同时服用标准抗关节炎药物。关节炎活动通过临床检查、美国风湿病学会（ACR）标准、斯坦福健康评估问卷残疾指数（HAQ-DI）以及红细胞沉降率（ESR）和 C 反应蛋白（CRP）的实验室检测进行评估。
接受凝结芽孢杆菌 GBI-30,6086 治疗的患者患者疼痛评估评分（P =.052）和疼痛量表（P =.046）有显著改善，与安慰剂相比，患者整体评估和自我评估残疾情况有所改善；CRP 降低；能够行走 2 英里，伸手和参与日常活动。在整个研究过程中，没有报告与治疗相关的不良事件。
这项初步研究的结果表明，凝结芽孢杆菌 GBI-30,6086 联合治疗 LAB 益生菌对 RA 患者似乎是一种安全有效的治疗方法。由于研究人群规模较小，需要更大规模的试验来验证这些结果。
ACTRN12609000435280。
