Associations Between Dietary Intake of Vitamin K and Changes in Symptomatic and Structural Changes in Patients With Knee Osteoarthritis.

OBJECTIVE: To investigate associations of dietary vitamin K intake with changes in knee symptoms and structures in patients with knee osteoarthritis (OA). METHODS: Participants with symptomatic knee OA were enrolled (n = 259) and followed up for 2 years (n = 212). Baseline dietary vitamin K intake was calculated from a validated food frequency questionnaire. Knee symptoms were assessed by using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scores. Knee cartilage defects, bone marrow lesions, and effusion-synovitis volume were measured from magnetic resonance imaging (MRI) scans. Univariable and multivariable linear regressions were used for analyses. RESULTS: A higher vitamin K intake quartile was significantly associated with a greater decrease in the total WOMAC score and dysfunction score over 24 months. The subgroup analyses showed in patients with severe baseline visual analog scale (VAS) pain that a higher vitamin K intake quartile was associated with more improvement in all WOMAC scores. There were no overall significant associations between vitamin K intake and changes in MRI features. In subgroup analysis, vitamin K intake was negatively associated with changes in tibiofemoral, patellar, and total cartilage defects in participants with a severe baseline radiographic grade and was negatively associated with change in total and patellar cartilage defects in participants with severe baseline VAS pain and in female patients. CONCLUSION: The association of higher vitamin K intake with decreased knee symptoms over 24 months in patients with knee OA suggests that clinical trials examining the effect of vitamin K supplementation for knee OA symptoms are warranted. Whether there is an effect on knee structure is unclear.

Efficacy and safety of Fengshi Gutong Capsule in patients with active ankylosing spondylitis: A 4-week randomized controlled, double-blinded, double-dummy trial.

ETHNOPHARMACOLOGICAL RELEVANCE: Fengshi Gutong Capsule (FSGTC) is a traditional Chinese herbal medicine that is composed of seven herbs. It has been widely used for the treatment of joint pain in China. However, the clinical evidence supporting its use in patients with ankylosing spondylitis (AS) is lacking. AIM OF THE STUDY: This study aims to explore the efficacy and safety of FSGTC in the treatment of AS. MATERIALS AND METHODS: This randomized, controlled, double-blinded, double-dummy trial enrolled patients with active AS defined as Bath Ankylosing Spondylitis Disease ActivityIndex (BASDAI) ≥ 4 or Ankylosing Spondylitis Disease Activity Score with C-reactive protein (ASDAS-CRP) ≥ 2.1. Eligible patients were randomized (1:1:1) into combination group (FSGTC plus imrecoxib), FSGTC group (FSGTC plus imrecoxib placebo) or imrecoxib group (imrecoxib plus FSGTC placebo) over a 4-week treatment. The primary endpoint was the composite outcome measure of the Assessment in Ankylosing Spondylitis 20% (ASAS20) response at week 4. The secondary endpoints included ASDAS-CRP, BASDAI, Bath Ankylosing Spondylitis Functional Index (BASFI), Bath Ankylosing Spondylitis Metrology Index (BASMI), patient's global assessment of disease activity (PGTA) and safety. RESULTS: Of the 180 randomized patients, 159 patients (88.3%) completed the 4-week treatment. ASAS20 response rate at week 4 was achieved by 27.5% in imrecoxib group, compared with 37.0% in combination group (P > 0.05) and 37.0% in FSGTC group (P > 0.05). In comparison to imrecoxib group, there were significantly greater improvements of ASDAS-CRP and PTGA in combination group and greater improvement of ASDAS-CRP in FSGTC group while the rest of the secondary endpoints shown similar improvement. The incidence of gastrointestinal adverse events in imrecoxib group (15.7%) was significantly higher than that of FSGTC group (1.9%) and without a significant difference to combination group (7.4%). CONCLUSION: FSGTC alone or combined with NSAIDs has therapeutic efficacy in decreasing disease activity of active AS patients and with good gastrointestinal tolerability after 4-week of treatment.

Effects of Vitamin D Supplementation on Disabling Foot Pain in Patients With Symptomatic Knee Osteoarthritis.

OBJECTIVE: The present study was undertaken to determine whether vitamin D supplementation or maintaining sufficient vitamin D level reduces foot pain over 2 years in patients with symptomatic knee osteoarthritis (OA). METHODS: A post hoc study was conducted from a randomized, double-blind, placebo-controlled trial named the Vitamin D Effect on Osteoarthritis (VIDEO) study. Symptomatic knee OA patients with serum 25-hydroxyvitamin D levels between 12.5 nmoles/liter and 60 nmoles/liter were included and randomly allocated to either monthly vitamin D3 or placebo treatment (1:1) for 2 years. Manchester Foot Pain and Disability Index (MFPDI) was used to evaluate foot pain and disabling foot pain was defined as at least 1 of the 10 functional limitation items (items 1-9 and 11) being documented as on "most/every day(s)" in the last month. A repeated-measures, mixed-effects model was used to analyze the change of MFPDI scores between groups adjusting for potential confounders. RESULTS: A total of 413 patients with a mean age of 63.2 years (49.7% males) were enrolled and 340 completed the study. The mean MFPDI score was 22.8 ± 7.3, with 23.7% of participants having disabling foot pain at baseline. There were significant differences in MFPDI scores change between groups over 2 years, with more improvements in the vitamin D group than in the placebo group (-0.03 versus 1.30; P = 0.013) and more improvement in those maintaining sufficient vitamin D levels (n = 226) than those who did not (n = 114) (-0.09 versus 2.19; P = 0.001). CONCLUSION: Vitamin D supplementation and maintenance of sufficient vitamin D levels may improve foot pain in those with knee OA.

Effect of Vitamin D Supplementation on Depressive Symptoms in Patients With Knee Osteoarthritis.

OBJECTIVES: To determine the effect of vitamin D supplementation and maintaining sufficient serum vitamin D on depressive symptoms in patients with knee osteoarthritis (OA) and vitamin D deficiency. DESIGN: A prespecified secondary analysis of a multicentre, randomized, double-blind, placebo-controlled trial. Participants were randomly assigned to receive oral vitamin D3 (50,000 IU, n = 209) or placebo (n = 204) monthly for 24 months. In addition, participants who completed the trial were classified into 2 groups according to their serum 25(OH)D levels at month 3 and 24 as follows: not consistently sufficient (serum 25(OH)D ≤ 50 nmol/L at month 3 and/or 24), and consistently sufficient (serum 25(OH)D > 50 nmol/L at both month 3 and 24). Multilevel mixed-effect models were used to compare differences of change in PHQ-9 scores between groups. SETTING AND PARTICIPANTS: This clinical trial was conducted in participants with symptomatic knee OA and vitamin D deficiency from June 2010 to December 2013 in Tasmania and Victoria, Australia. MEASURES: The primary outcome was the depressive symptoms change over 24 months, which was measured using the Patient Health Questionnaire (PHQ-9, 0-27). RESULTS: Of 599 participants who were screened for eligibility, 413 participants were enrolled (mean age: 63.2 years; 50.3% female) and 340 participants (intervention n = 181, placebo n = 159, 82.3% retention rate) completed the study. The baseline prevalence of depression (PHQ-9 score ≥5) was 25.4%. Depressive symptoms improved more in the vitamin D supplementation group compared to the placebo group [ß: -0.66, 95% confidence interval (CI): -1.22 to -0.11, P for difference = .02] and in the participants who maintained vitamin D sufficiency compared to those who did not (ß: -0.73, 95% CI: -1.41 to -0.05, P for difference = .04) over 24 months. CONCLUSIONS/IMPLICATIONS: These findings suggest that vitamin D supplementation and maintaining adequate vitamin D levels over 24 months may be beneficial for depressive symptoms in patients with knee OA.