Introduction: The mixture of Beta-sitosterol (BSS) and Beta-sitosterol glucoside (BSSG) has demonstrated anti-inflammatory activities in vitro, inhibiting the secretion of IL6 and TNF-alpha from activated monocytes. Both factors are implicated in the pathogenesis of RA.
Objective: Could the BSS: BSSG mixture result in the improvement of active RA as assessed by ACR 20% response criteria?
Methods: After a two-week placebo run-in phase, patients with active RA were randomized to receive either 20mg BSS/0.2mg BSSG capsules tid or placebo (225mg carrier) tid for 24 weeks. Mean demographics of the patient groups were similar. All patients had active RA as defined by ACR criteria. Stable DMARD doses were required for 3 months prior to the start and for the duration of the study. No new DMARD therapy could be initiated during the study. Patient response was assessed in terms of ACR response criteria (>20% improvement). Significant changes between active and placebo groups were calculated with the Kruskal-Wallis 2-sample test. Changes within a group relative to baseline were calculated with the Wilcoxon rank test.
Results: 18 Patients were enrolled (8 on actives and 10 on placebo). In the active group, statistically significant changes were measurable in the mean tender joint count (85% ACR response); patient's assessment of pain (28% response); patient's global assessment of disease activity (33% response); physician's global assessment of pain (47%) and the MHAQ decreased (47% response). The ESR also decreased significantly (56% response). The placebo group had no significant improvement in the ACR 20% improvement criteria. At 24 weeks, significant differences between groups with regards to tender joint count, MHAQ, physician's global assessment and patient's assessment of disease activity were demonstrated. The BSS: BSSG mixture was well tolerated and no serious adverse events were recorded. |
