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BACKGROUND & AIM: The role of vitamin D deficiency in fibromyalgia (FM) pathogenesis is not clearly understood. In this study, we evaluated the association of serum vitamin D status of FM patients with laboratory indices of inflammation, as well as clinical indices of FM. MATERIALS & METHODS: Ninety-two female FM patients with a mean age of 42.4 ± 7.4 years were included in this cross-sectional study. Serum vitamin D, serum IL-6, and serum IL-8 levels were evaluated using an enzyme-linked immunosorbent assay. Serum vitamin D levels were categorized as deficient (<20 ng/ml), insufficient (20-30 ng/ml), and sufficient (30-100 ng/ml). The clinical severity of the disease was assessed by the fibromyalgia impact questionnaire (FIQ) and widespread pain index (WPI). RESULTS: The mean serum IL-6 level was significantly higher in vitamin D-deficient patients in comparison with vitamin D-sufficient patients (P = 0.039). The mean serum IL-8 level was also significantly higher in vitamin D-deficient patients in comparison with vitamin D-sufficient patients (P < 0.001). A significant positive correlation was found between the serum IL-8 level and FIQ scores (r = 0.389, p = 0.001) and the WPI of the patients (0.401, p < 0.001). Serum IL-6 level was significantly correlated with the WPI of the patients (r = 0.295, p = 0.004), but not with FIQ scores (r = 0.134, p = 0.066). Serum vitamin D status was not associated with either FIQ scores or WPI. CONCLUSION: In FM patients, serum vitamin D deficiency is associated with higher levels of serum pro-inflammatory cytokines, and higher levels of serum pro-inflammatory cytokines are associated with greater FM impact.

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Background: There is no clear consensus regarding the potential of denosumab for increasing the risk of infection in patients who concurrently receive biologic disease-modifying anti-rheumatic drugs (bDMARDs). In this study, we compared the rate of infection in postmenopausal women with rheumatoid arthritis who received concurrent bDMARDs and denosumab with those who received bDMARDs alone. Methods: In a case-control study, postmenopausal patients with a confirmed diagnosis of rheumatoid arthritis who received concurrent bDMARDs and denosumab for at least one year were identified and included as the case group (n=40). A total of 44 age-matched postmenopausal rheumatoid arthritis women who received bDMARDs alone were included as the control group of the study. Using a chi-squared test, the incidence of bacterial or viral infections was extracted from the patients' profiles and compared between the two study groups. Statistical analyses were performed by SPSS for Windows, version 16 (Chicago, Illinois, USA). A p-value of fewer than 0.05 was regarded as significant. Results: The clinical and demographic characteristics of the patients of the two study groups were not significantly different. In total, four infections were recorded in the present series, two infections in each group. Accordingly, the rate of infection was 4.5% in the bDMARDs alone group and 5% in bDMARDs + denosumab group. This difference was not statistically significant (p=0.655, 95% CI: 0.121-6.742). Three out of four infections were herpes zoster infection. The other one was osteomyelitis of the first metatarsal bone, which occurred in the bDMARDs+denosumab group. None of the infections needed a hospitalization of IV antibiotics. Conclusion: The risk of infection is comparable between postmenopausal osteoporotic women with rheumatoid arthritis who receive bDMARDS alone and those who receive bDMARDS in combination with denosumab.

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OBJECTIVE: The role of vitamin D in the pathogenesis of osteoarthritis (OA) is not well understood. In this study, we aimed to investigate the association of serum vitamin D with the serum cytokine profile in patients with primary knee OA. DESIGN: In a cross-sectional study, 116 patients with radiologic diagnosis of grade I to III knee OA were included. The study population included 79 (75.9%) females and 25 (24.1%) males with a mean age of 55.1 ± 9.6 years. The serum concentration of IL-6, IL-8, TNF-α, IL-4, IL-10, IL-13, and vitamin D were assessed using an enzyme-linked immunosorbent assay. The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) was used for the assessment of patient's reported disability associated with knee OA. RESULTS: Serum vitamin D status was deficient, insufficient, and sufficient in 18 (15.5%), 63 (54.3%), 35 (30.2%) patients, respectively. Higher levels of serum IL-6 were observed in patients with vitamin D deficiency (P = 0.022). The mean serum vitamin D level was not associated with OA grade (P = 0.88) and WOMAC scores of the patients (P = 0.67). Serum IL-6 level was significantly associated with both OA grade and WOMAC scores of the patients (P < 0.001 and P = 0.001, respectively). The vitamin D status was not significantly associated with the serum levels of other evaluated cytokines. CONCLUSION: Vitamin D deficiency in knee OA seems to be associated with a higher release of IL-6. Therefore, vitamin D supplementation could reduce the disease burden by controlling the IL-6 release.

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OBJECTIVE: The identification of early-stage osteoarthritis (OA) is crucial for the deceleration of its progression; however, no reliable biomarker is available for this purpose. The current study aimed to determine the role of serum calprotectin in the detection of early-stage knee OA. DESIGN: In a case-control study, serum samples were collected from 84 patients with primary bilateral knee OA and 52 healthy controls. The radiographic grading of knee OA was performed using the Kellgren-Lawrence classification system. Serum concentrations of calprotectin were measured using an enzyme-linked immunosorbent assay. RESULTS: The mean serum calprotectin level was 2908 ± 2516 ng/mL in OA patients and 901 ± 875 ng/mL in healthy control subjects (P < 0.001). Mean serum calprotectin levels were significantly higher in the lower stages of OA: 3740 ± 2728 ng/mL in OA grade I, 3100 ± 2084 ng/mL in OA grade II, 2246 ± 1418 ng/mL in OA grade III, and 2035 ± 765 ng/mL in OA grade IV (P = 0.047). Serum calprotectin levels were significantly higher in patients with a disease duration <42 months compared with those with a disease duration >42 months (P = 0.043). CONCLUSION: Serum calprotectin level increases significantly in the early stages of OA and shows a reverse association with disease severity. Therefore, it could be suggested as a promising blood-based marker for early-stage knee OA.

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INTRODUCTION: Trabecular Bone Score (TBS) is an index of bone microarchitecture independent of Bone Mineral Density (BMD). Recently, TBS data has been used to optimize the predictive value of the Fracture Risk Assessment Tool (FRAX). The aim of this study was to evaluate the clinical value of FRAX adjustment with TBS in kidney transplant recipients. METHODS: Seventy post-transplant Iranian kidney recipients were included in this study. After the evaluation of BMD and TBS, the risk of major osteoporotic fracture (MOF) and hip fracture (HF) was assessed once with and once without TBS adjustment. The proportion of patients who needed a therapeutic intervention was compared before and after TBS adjustment. The association between TBS and BMD data was also evaluated. RESULTS: The mean age of the patients was 54 ± 8.8 years (range: 40 to 77). The mean TBS of the patients was 1.30 ± 0.12. In multivariate analysis, the TBS was significantly associated with the age (P < .05) and dialysis period (P < .05). A strong correlation was found between the spine BMD and TBS data (r = 0.612, P < .001). A significant correlation was found between the MOF and HF of the patients before and after adjustment for TBS. The proportion of patients needed a therapeutic intervention significantly increased from 17.1% to 25.7% after TBS adjustment of FRAX. CONCLUSION: Adjustment of FRAX with TBS will reclassify the treatment decision in a considerable number of kidney transplant recipients. This clinical value warrants the adjustment of FRAX data with TBS in future workouts.

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BACKGROUND & AIMS: The balance between oxidants and antioxidants is known as oxidative balance, which is impaired in many disease conditions such as osteoarthritis (OA). In this study, we aimed to evaluate this balance in OA patients through the evaluation of the oxidant to the antioxidant ratio. MATERIALS AND METHODS: A total of 62 knee OA patients and 20 age, sex, and BMI-matched healthy controls were included in this cross-sectional study. Serum total oxidant status (TOS) and total antioxidant capacity (TAC) were evaluated using the oxidation-reduction colorimetric assay. The TOS to TAC ratio (TOS/TAC) was evaluated as an estimate of the oxidant to antioxidant balance. RESULTS: The mean TOS was 14.2 ± 2 µM in the healthy controls and 23.3 ± 7 µM in the OA patients (p < 0.001). The mean TAC was 38.8 ± 6.6 µM in the healthy subjects and 35.8 ± 12 µM in the OA patients (p = 0.33). The mean TOS/TAC was 0.38 ± 0.09 in the healthy subjects and 0.72 ± 0.3 in the OA patients (p < 0.0001). TOS/TAC value was capable of distinguishing OA patients from healthy controls with the sensitivity and specificity of 87.1% and 80%, respectively (p < 0.001). At the cutoff value of 0.46, positive TOS/TAC (>0.46) was identified in 100% of grade I patients, whereas it was negative in 27.3%, 16.7%, and 16.7% of grades II, III, and IV, respectively (p = 0.039). CONCLUSION: In the knee OA, an equation of the serum TOS to TAC could be a good representative of oxidative balance than each component individually.

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The available pharmacological modalities for the treatment of fibromyalgia (FM) are associated with a variety of adverse effects and limited benefits. In this study, we systematically reviewed the impact of melatonin in the treatment of FM. Interventional studies, either controlled or uncontrolled and randomized or non-randomized, were included. PubMed, EMBASE, Scopus, Web of Science, and the Cochrane Library were searched without time limitation. Primary outcome measures were the effect of melatonin on the disease impact, pain, sleep quality, tender point count, fatigue, anxiety, stiffness, and depression in FM patients. Four studies, reporting the effect of melatonin on 98 patients, were eligible to include. All the studies reported the positive effect of melatonin on the FM symptoms. No major adverse event was reported. A significant level of heterogeneity was observed between the studies. Therefore, further high-quality controlled clinical trials are needed to understand the role of melatonin in FM treatment fully.

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BACKGROUND AND STUDY AIMS: Non-invasive biomarkers of inflammatory bowel diseases (IBD) are of critical importance. Here, we evaluated the S100A8 and S100A9 mRNA expression, as the heterodimers of calprotectin, in the blood leucocytes of IBD patients to find how their expression associates with the disease characteristics. PATIENTS AND METHODS: In this cross-sectional study, 59 IBD patients and 30 healthy subjects were included. The flare and remission phases of disease were identified in 46 and 13 patients, respectively. Blood leucocytes were isolated, and the S100A8 and S100A9 mRNA expression were evaluated in the isolated leucocytes using relative quantification real-time PCR. RESULTS: The mean S100A8 and S100A9 mRNA expression were significantly higher in IBD patients than in the controls (p = 0.03 and p = 0.02, respectively). The mean S100A8 and S100A9 mRNA expression were significantly higher in the flare phase of the disease compared with the remission phase (p = 0.01 and p = 0.007, respectively). S100A8 distinguished IBD patients from controls with the sensitivity and specificity of 73% and 64%, and flare phase of disease from remission with the sensitivity and specificity of 67% and 62%. On the other hand, S100A9 distinguished IBD patients from controls with the sensitivity and specificity of 81% and 70%, and flare phase of disease from remission with the sensitivity and specificity of 68% and 64%. CONCLUSION: The S100A8 and S100A9 mRNA are differentially expressed in blood leucocytes of IBD patients compared to healthy controls as well as active versus quiescent disease. Thus, they can be potentially used as a blood-based biomarker in the monitoring of IBD.

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As the incidence of inflammatory bowel diseases (IBD) increases in the newly industrialized countries, the health and financial burden of disease also increase. These changes make the role of IBD biomarkers further crucial. Serum calprotectin, as a novel blood-based biomarker of IBD, has been investigated in several investigations. Yet, there is no consensus regarding its clinical utility. We searched the electronic database, including PubMed, EMBASE, Scopus, and Web of Science up to the end of 2018 to find how serum calprotectin associates with the disease characteristics in IBD. The search terms included: inflammatory bowel diseases, IBD, Crohn Diseases (CD), Ulcerative Colitis (UC), calprotectin, serum, and blood. Based on our review, a biomarker role has been suggested for serum calprotectin in IBD, as significant associations were found between serum calprotectin and disease burden, prognosis, and relapse. A complementary role to fecal calprotectin has also been suggested for serum calprotectin. On the other hand, considering a significant correlation between serum calprotectin and serum CRP, but not fecal calprotectin, serum calprotectin could be more representative of systemic inflammation than an intestinal inflammation. Consequently, further researches are needed to unwrap the potential of serum calprotectin as a blood-based biomarker in IBD.

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OBJECTIVES: There is no consensus over the effect size of cognitive behavioral therapy (CBT) in the treatment of fibromyalgia (FM). This study aims to evaluate the effect of CBT on FM patients, through assessing circulating proinflammatory cytokines. METHODS: A controlled, single-blind, parallel clinical trial was performed with 21 FM patients in each group. Sixteen FM patients in the intervention group (CBT) and 17 FM patients in the control group (waiting-list) completed the study. For the intervention group, traditional face-to-face CBT was performed for groups of 10 and 11 patients in 20 sessions. Fibromyalgia Impact Questionnaire (FIQ), widespread pain index (WPI), circulating IL-6, IL-8, and TNF-α level were evaluated before and after the intervention using enzyme-linked immunosorbent assay. Intention-to-treat analysis was performed as the primary analysis. RESULTS: The average changes of factors examined were as follows: FIQ score -0.61 ±â€¯5.5 in the waiting-list group and 10.2 ±â€¯14.9 in the CBT group (p = 0.012); WPI -0.33 ±â€¯1.1 in the waiting-list group and 2.4 ±â€¯3.1 in the CBT group (p = 0.002); serum IL-6 level -0.05 ±â€¯0.86 pg/ml in the waiting-list group and 1.5 ±â€¯2.4 pg/ml in the CBT group (p = 0.002); serum IL-8 level - 0.55 ±â€¯0.2.5 pg/ml in the waiting-list group and 5 ±â€¯5.9 pg/ml in the CBT group (p = 0.002); serum TNF-α level 0.67 ±â€¯1.8 pg/ml in the waiting-list group and 0.7 ±â€¯1.6 pg/ml in the CBT group (p = 0.89). CONCLUSION: Reductions in proinflammatory cytokines after CBT compared with a waiting-list control group confirm the potential value of these biomarkers as surrogate outcome measures in FM.

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AIM: Here we aimed at evaluating whether the apoptosis status of circulating leukocytes of inflammatory bowel diseases (IBD) patients is attributed to the diseases clinical status. BACKGROUND: Defects in the programmed cell death of inflammatory cells is known as to play a major role in the pathogenesis of IBD, and has been associated with the clinical efficacy of therapeutic agents. METHODS: A total of 50 IBD patients, 25 with remission and 25 with flare-up phase of the disease, who their disease was confirmed by colonoscopy, were included in this cross-sectional study. Pro-apoptotic Bax and anti-apoptotic Bcl-2 mRNA expression, along with Bax/Bcl-2 ratio, as measures of apoptotic status, were assessed in the Peripheral blood mononuclear cell (PBMC) of the patients using semi-quantitative Real-time PCR method. RESULTS: The mean Bax mRNA expression level was 0.54±0.12 in flare-up group and 0.53±0.13 in remission group (p=0.8). The mean Bcl-2 mRNA expression level was 0.63±0.13 in flare-up group and 0.55±0.12 in remission group (p=0.03). The mean Bax/Bcl-2 ratio was 0.88±0.17 in flare-up group and 1±21 in remission group (p=0.05). The mean Bax/Bcl-2 ratio was not statistically significant between different disease types (p=0.54) or therapeutic agents (p=0.7). CONCLUSION: According to our results, alteration in markers of apoptosis could be traced in the circulating leukocytes of IBD patients, which suggest a potential for clinical application of apoptosis markers in disease monitoring and prediction of relapse.

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AIM: Here, we evaluated the role of (iNOS) as a blood-based biomarker of inflammatory bowel diseases (IBD). BACKGROUND: Up-regulation of inducible nitric oxide synthase (iNOS) in the intestinal epithelial cells has been closely associated with the initiation and maintenance of intestinal inflammation in IBD. METHODS: In a case-control design, 59 IBD patients and 30 healthy control subjects were participated in this study. A total of 10 ml blood sample was taken from each participant. Blood leukocytes were isolated and iNOS mRNA expression level was evaluated in the isolated leukocytes using relative quantitative Real-time PCR. RESULTS: The patients' population included 40 ulcerative colitis (UC) and 19 Crohn's disease (CD) patients. The flare and remission phase of disease were seen in 43 and 16 patients, respectively. The mean iNOS mRNA expression was not significantly different between the IBD patients and healthy controls (p=0.056). The mean iNOS mRNA expression was significantly higher in the flare phase of the disease compared to the remission phase (p=0.039). No significant difference was observed between the mean iNOS mRNA expression in the blood leukocytes of UC and CD patients (p=0.82). CONCLUSION: iNOS is differently expressed in the blood leukocytes of active vs. inactive IBD disease. Thus, it could be potentially used as a non-invasive blood-based biomarker of IBD.

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This corrects the article DOI: 10.1038/ctg.2017.44.

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OBJECTIVES: Anti-tumor necrosis factor (TNF)-α agents like Infliximab (IFX) are effective in the treatment of inflammatory bowel diseases (IBDs) and are widely used. However, a considerable number of patients do not respond or lose response to this therapy. Preliminary evidence suggests that transmembrane TNF-α (tmTNF-α) might be linked to response to IFX by promoting reverse signaling-induced apoptosis in inflammatory cells. The main aim of this study was the evaluation of this hypothesis in primary IFX non-responders. METHODS: A total of 47 IFX naive IBD patients were included in the study. Blood samples were taken before the start of IFX therapy (at week 0) and after induction therapy (at week 14). Endoscopic disease activity and markers of inflammation at baseline and at week 14 were used to evaluate response. Baseline soluble TNF-α (sTNF-α), percentage of circulating TNF-α positive cells, mean fluorescence intensity (MFI) of tmTNF-α, and apoptosis rate at week 14 in the peripheral blood mononuclear cells (PBMCs) were evaluated in IFX responders and non-responders. RESULTS: Mean sTNF-α was not significantly different in responders compared to non-responders (P=0.13). Mean percentage of tmTNF-α bearing lymphocytes and monocytes was higher in the PBMCs of responders (P=0.05 and P=0.014, respectively). Mean MFI of tmTNF-α in circulating lymphocytes and monocytes was greater in responders (P=0.002 and P<0.001, respectively). Moreover, the mean percentage of apoptosis in PBMCs was significantly greater in responders compared to non-responders (P=0.002). CONCLUSIONS: The percentage of tmTNF-α bearing lymphocytes and monocytes and the intensity of tmTNF-α in the circulating leukocyte population of IBD patients was directly related to primary response to IFX. This was likely due-as assessed by the apoptosis rate-to promotion of inflammatory cell death. Thus, our data suggest that peripheral leukocytes could in principle be used for predicting primary response to IFX in IBD patients.