Amoxicillin Did Not Reduce Modic Change Edema in Patients With Chronic Low Back Pain: Subgroup Analyses of a Randomised Trial (the AIM Study).

STUDY DESIGN: Exploratory subgroup analyses of a randomised trial [Antibiotics in Modic changes (AIM) study]. OBJECTIVE: The aim was to assess the effect of amoxicillin versus placebo in reducing Modic change (MC) edema in patients with chronic low back pain. SUMMARY OF BACKGROUND DATA: The AIM study showed a small, clinically insignificant effect of amoxicillin on pain-related disability in patients with chronic low back pain and MC type 1 (edema type) on magnetic resonance imaging (MRI). MATERIALS AND METHODS: A total of 180 patients were randomised to receive 100 days of amoxicillin or placebo. MC edema was assessed on MRI at baseline and one-year follow-up. Per-protocol analyses were conducted in subgroups with MC edema on short tau inversion recovery (STIR) or T1/T2-weighted MRI at baseline. MC edema reductions (yes/no) in STIR and T1/T2 series were analyzed separately. The effect of amoxicillin in reducing MC edema was analyzed using logistic regression adjusted for prior disk surgery. To assess the effect of amoxicillin versus placebo within the group with the most abundant MC edema on STIR at baseline ("STIR3" group), we added age, STIR3 (yes/no), and STIR3×treatment group (interaction term) as independent variables and compared the marginal means (probabilities of edema reduction). RESULTS: Compared to placebo, amoxicillin did not reduce MC edema on STIR (volume/intensity) in the total sample with edema on STIR at baseline (odds ratio 1.0, 95% CI: 0.5, 2.0; n=141) or within the STIR3 group (probability of edema reduction 0.69, 95% CI: 0.47, 0.92 with amoxicillin and 0.61, 95% CI: 0.43, 0.80 with placebo; n=41). Compared with placebo, amoxicillin did not reduce MC edema in T1/T2 series (volume of the type 1 part of MCs) (odds ratio: 1.0, 95% CI: 0.5, 2.3, n=104). Edema declined in >50% of patients in both treatment groups. CONCLUSIONS: From baseline to one-year follow-up, amoxicillin did not reduce MC edema compared with placebo. LEVEL OF EVIDENCE: 2.

Association between vitamin D and fatigue in patients with rheumatoid arthritis: a cross-sectional study.

OBJECTIVES: In rheumatoid arthritis (RA), fatigue is an important complaint with a significant impact on quality of life. Vitamin D has modulatory effects on cells of the immune system and may potentially affect RA disease activity and thereby RA-related fatigue. The purpose of this study was to explore associations between fatigue and vitamin D status in patients with RA. DESIGN: Hypothesis-generating cross-sectional study. SETTING: Scheduled follow-up visits at a hospital-based general rheumatology clinic. PARTICIPANTS: Patients (n=169) with established RA. PRIMARY OUTCOME MEASURES AND ANLYSES: Fatigue, assessed by the Chalder fatigue questionnaire, and serum concentrations of 25-hydroxyvitamin D (25(OH)D), assessed by liquid chromatography-tandem mass spectrometry. Associations were analysed by correlation, and multivariate linear regression with adjustments for age, sex, body mass index, RA disease activity as measured by the Disease Activity Score 28-joint count C reactive protein (DAS28-CRP), psychological distress, pain and sleep. Fatigue was also compared across four groups based on the levels of serum 25(OH)D with cut points at 30, 50 and 75 nmol/L using one-way analysis of variance. RESULTS: Two-thirds of the patients (116/169, 69%) were classified with low RA disease activity, that is, a DAS28-CRP score below 3.2. Their mean (SD) serum 25(OH)D concentration was 56.3 (21.2) nmol/L, with 77 (45.6%) having values below 50 nmol/L and 12 patients (7.1%) below 30 nmol/L. The correlation between fatigue and serum concentrations of 25(OH)D was weak and not statistically significant, r = -0.14 (95% CI: -0.29 to 0.03, p=0.08). In the multivariate model, fatigue was significantly associated with RA disease activity, psychological distress and pain, but not with serum 25(OH)D. Fatigue did not differ across groups with varying levels of serum 25(OH)D. CONCLUSION: This cross-sectional study found no evidence of association between vitamin D and fatigue in patients with RA.

Subjective health complaints in patients with lumbar radicular pain and disc herniation are associated with a sex - OPRM1 A118G polymorphism interaction: a prospective 1-year observational study.

BACKGROUND: Earlier observations show that development of persistent pain may be associated with the genetic variability in the gene encoding for the µ-opioid receptor 1, the OPRM1 A118G (rs1799971). The aim of this study was to investigate the association between OPRM1 genotype and subjective health complaints in patients with radicular pain and disc herniation. METHODS: A prospective, 1-year observational study was conducted at a hospital back clinic, including 118 Caucasian patients with lumbar radicular pain and MRI confirmed disc herniation. Single nucleotide polymorphism genotyping regarding the OPRM1 A118G was performed. The data of individuals with AA versus AG or GG were analysed separately by linear mixed models. The Subjective Health Complaints Inventory (0-81) including 27 common complaints experienced the previous month on a scale from not at all (0) to severe (3) was used as outcome. Pain, prior duration of leg pain, age, smoking status, and lumbar disc surgery were considered as covariates. RESULTS: In total 23 of 118 patients were carriers of the OPRM1 G-allele. All patients except female carriers of the G-allele reported a decrease in pain from baseline to 1 year. Female carriers of the G-allele reported significantly higher subjective health complaints score during the study time span than male carriers of the G-allele when controlling for pain and pain duration. CONCLUSION: The present data indicate that, when controlling for pain intensity and duration, subjective health complaints are associated with a sex - OPRM1 A118G polymorphism interaction in patients with radicular pain.