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Introduction Fibromyalgia is characterized by widespread pain and is often accompanied by accessory symptoms. There are limited treatment options for this condition in Japan. Therefore, we conducted a phase III study to assess the efficacy and safety of duloxetine in Japanese patients with fibromyalgia. Methods This randomized, double-blind, placebo-controlled, parallel-group trial was conducted in Japan. Outpatients who met the American College of Rheumatology 1990 criteria for fibromyalgia and whose Brief Pain Inventory (BPI) average pain score was ≥4 were randomized to duloxetine 60 mg or placebo once daily for 14 weeks. The primary efficacy measure was the change in the BPI average pain score from baseline. Secondary efficacy, quality of life (QoL), and safety outcomes were also evaluated. Mixed-effects model repeated-measures (MMRM) analysis and last observation carried forward (LOCF) analysis of covariance were used to evaluate the primary efficacy measure. Results Overall, 393 patients were randomized to receive either duloxetine (n = 196) or placebo (n = 197). The MMRM analysis revealed no significant difference between duloxetine and placebo regarding the change in BPI average pain scores at week 14. Based on LOCF analysis, a statistically significant improvement in the change in BPI average pain scores at week 14 was observed for patients treated with duloxetine compared with placebo. Duloxetine treatment was associated with improved outcomes in nearly all secondary and post hoc analyses. The treatment was generally well tolerated. Somnolence, nausea, and constipation were the most common treatment-emergent adverse events in the duloxetine group. The discontinuation rates due to treatment-emergent adverse events were similar in both groups. Conclusions Although the MMRM analysis did not demonstrate superiority of duloxetine over placebo, duloxetine treatment was associated with improved outcomes in secondary and post hoc analyses of the mean change in the BPI average pain score and most of the secondary outcomes, including analgesia and QoL. Duloxetine treatment was safe and well tolerated. These results suggest that duloxetine treatment could be associated with improvements in pain relief and QoL in Japanese patients with fibromyalgia. Trial registration ClinicalTrials.gov Identifier: NCT01552057 . Registered 9 March 2012.

Background and Objectives: To examine the prevalence of fibromyalgia syndrome (FMS) in patients with psoriasis (PsO) and psoriatic arthritis (PsA) and its impact on treatment patterns and biologic therapy adherence. Materials and Methods: This retrospective cohort study utilized electronic health records from the Meuhedet Health Maintenance Organization in Israel between 2000 and 2020. PsO patients were matched 1:4 with controls by age, sex, and ethnicity. We assessed FMS prevalence, comorbidity burden, and treatment patterns. Cox regression and linear models evaluated the association between FMS and biologic switching and duration, adjusting for confounders. Results: Among 61,003 PsO patients and 244,012 controls, FMS prevalence was higher in PsO (3.3% vs. 2.3%, OR = 1.45, 95% CI: 1.38–1.53, p < 0.001). Among PsO patients, those with FMS were predominantly female (81.1% vs. 49.8%, p < 0.001) and had a higher prevalence of PsA (33.6% vs. 7.7%, p < 0.001). They received biologics more frequently (10.2% vs. 2.7%, p < 0.001) and were more likely to require multiple biologic lines (4.2% vs. 0.7%, p < 0.001). In PsA patients receiving biologics, FMS was associated with reduced survival on first-line therapy (6.1 vs. 10.1 years), increased switching risk (HR = 1.82, 95% CI: 1.42–2.35), and shorter treatment duration (B= −0.97 years, p = 0.001). Conclusions: In PsO patients, especially those with psoriatic arthritis, FMS is linked to greater treatment complexity and shorter biologic therapy survival, underscoring the need for tailored management strategies.

Fibromyalgia (FMS) is a chronic pain syndrome with a complex but poorly understood pathogenesis affecting approximately 10 million adults in the United States. The lack of a clear etiology of FMS has limited the effective diagnosis and treatment of this debilitating condition. The objective of this secondary data analysis was to examine plasma cytokine levels in women with FMS using the Bio-Plex Human Cytokine 17-plex Assay. Post hoc analysis of plasma cytokine levels was performed to evaluate patterns that were not specified a priori. Upon examination, patients with FMS exhibited a marked reduction in T H 2 cytokines such as IL-4, IL-5, and IL-13. The finding of this pattern of altered cytokine milieu not only supports the role of inflammation in FMS but also may lead to more definitive diagnostic tools for clinicians treating FMS. The T H 2 suppression provides strong evidence of immune dysregulation in patients with FMS.

Background A consistent line of investigation suggests that autonomic nervous system dysfunction may explain the multi-system features of fibromyalgia (FM); and that FM is a sympathetically maintained neuropathic pain syndrome. Dorsal root ganglia (DRG) are key sympathetic-nociceptive short-circuit sites. Sodium channels located in DRG (particularly Nav1.7) act as molecular gatekeepers for pain detection. Nav1.7 is encoded in gene SCN9A of chromosome 2q24.3 and is predominantly expressed in the DRG pain-sensing neurons and sympathetic ganglia neurons. Several SCN9A sodium channelopathies have been recognized as the cause of rare painful dysautonomic syndromes such as paroxysmal extreme pain disorder and primary erythromelalgia. The aim of this study was to search for an association between fibromyalgia and several SCN9A sodium channels gene polymorphisms. Methods We studied 73 Mexican women suffering from FM and 48 age-matched women who considered themselves healthy. All participants filled out the Fibromyalgia Impact Questionnaire (FIQ). Genomic DNA from whole blood containing EDTA was extracted by standard techniques. The following SCN9A single-nucleotide polymorphisms (SNP) were determined by 5' exonuclease TaqMan assays: rs4371369; rs4387806; rs4453709; rs4597545; rs6746030; rs6754031; rs7607967; rs12620053; rs12994338; and rs13017637. Results The frequency of the rs6754031 polymorphism was significantly different in both groups ( P = 0.036) mostly due to an absence of the GG genotype in controls. Interestingly; patients with this rs6754031 GG genotype had higher FIQ scores (median = 80; percentile 25/75 = 69/88) than patients with the GT genotype (median = 63; percentile 25/75 = 58/73; P = 0.002) and the TT genotype (median = 71; percentile 25/75 = 64/77; P = 0.001). Conclusion In this ethnic group; a disabling form of FM is associated to a particular SCN9A sodium channel gene variant. These preliminary results raise the possibility that some patients with severe FM may have a dorsal root ganglia sodium channelopathy.

The aim of the study was to investigate the validity and reliability of the Turkish version of the fatigue severity scale (FSS) in fibromyalgia (FM) patients. Sixty-one FM patients and 54 healthy controls were evaluated using the Turkish version of the FSS. Reliability was investigated using test–retest reliability and internal consistency. Concurrent validity was evaluated between the FSS score and the VAS fatigue. Convergent validity was assessed by comparing the FSS score with the scores of VAS pain, Beck Depression Inventory (BDI), Beck Anxiety Inventory (BAI), and Fibromyalgia Impact Questionnaire (FIQ). Spearman’s rank correlation coefficient was used to evaluate validity. Test–retest reliability and internal consistency of the FSS were excellent in FM patients (ICC: 0.94, Cronbach’s alpha coefficient: 0.85) and in the healthy controls (ICC: 0.90, Cronbach’s alpha coefficient: 0.91). For the concurrent validity, the correlation between the FSS and VAS fatigue was very good in FM group ( r : 0.63, P : 0.000) and in the healthy controls ( r : 0.94, P : 0.000). For the convergent validity, correlations between the FSS and BDI, BAI, FIQ, pain intensity were moderate to good in both groups ( P : 0.000). The Turkish version of the FSS has been proved to be valid and reliable to detect severity of fatigue in FM patients. We recommend the use of it in clinical practice.

Abstract Objective.  To assess the transcultural equivalency of the Spanish version of the Fibromyalgia Rapid Screening Tool (FiRST) and its discriminatory ability in different Latin American samples. Design.  Validation study. Setting.  Departments of Rheumatology in general hospitals and private centers; fibromyalgia unit in a university hospital. Subjects.  350 chronic pain patients from Spain, Argentina, Mexico, Peru, and Ecuador. Methods.  The cultural relevance of the Spanish version of the FiRST was evaluated. The ability of the FiRST as a screening tool for fibromyalgia was assessed by logistic regression analysis. To determine the degree to which potential confounders, such as differences in demographics, pain, affective distress, catastrophizing, and disability, might affect the discriminatory ability, the tool was reassessed by hierarchical multivariate logistic regression. Results.  Slightly different versions of the FiRST were recommended for use in each Latin American subsample. The FiRST showed acceptable criterion validity and was able to discriminate between fibromyalgia and non-fibromyalgia patients even after controlling for the effect of potential confounders. However, low specificities were observed in samples from Spain and Mexico. Conclusions.  The Spanish version of the FiRST may be used as a screening tool for fibromyalgia in several Latin American subsamples, even in those patients with high scores on potential confounders. In Spain and Mexico, the low specificity of the FiRST suggests, however, that it would be best used to support a suspected diagnosis of fibromyalgia, rather than to exclude the diagnosis.

Background Pain catastrophization has recently been recognized as a barrier to the healthy development of physical functioning among chronic pain patients. Levels of pain catastrophization in chronic pain patients are commonly measured using the Pain Catastrophizing Scale (PCS). Objective To cross-culturally adapt and validate the South African PCS (SA-PCS) among English-, Afrikaans- and Xhosa-speaking patients with fibromyalgia living in the Cape Metropole area, Western Cape, South Africa. Methods The original PCS was cross-culturally adapted in accordance with international standards to develop an English, Afrikaans and Xhosa version of the SA-PCS using a repeated measures study design. Psychometric testing included face/content validity, internal consistency (Cronbach’s alpha-α), test-retest reliability (intraclass coefficient correlations-ICC), sensitivity-to-change and cross-sectional convergent validity (by comparing the adapted SA-PCS to related constructs). Results The cross-culturally adapted English, Afrikaans and Xhosa SA-PCS showed good face and content validity, excellent internal consistency (with Chronbach’s α = 0.98, 0.98 and 0.97 for the English, Afrikaans and Xhosa SA-PCS, as a whole, respectively), excellent test-retest reliability (with ICC’s of 0.90, 0.91 and 0.89 for the English, Afrikaans and Xhosa SA-PCS, respectively); as well as satisfactory sensitivity-to-change (with a minimum detectable change of 8.8, 9.0 and 9.3 for the English, Afrikaans and Xhosa SA-PCS, respectively) and cross-sectional convergent validity (when compared to pain severity as well as South African versions of the Tampa scale for Kinesiophobia and the revised Fibromyalgia Impact Questionnaire). Conclusion The SA-PCS can therefore be recommended as simple, efficient, valid and reliable tool which shows satisfactory sensitivity-to-change and cross-sectional convergent validity, for use among English, Afrikaans and Xhosa-speaking patients with fibromyalgia attending the public health sector in the Western Cape area of South Africa.

This study was undertaken to translate and adapt the Fibromyalgia Impact Questionnaire (FIQ) into the Turkish language and investigate its validity and reliability for Turkish female fibromyalgia (FM) patients. After translation into Turkish, we administered the FIQ and Health Assessment Questionnaire (HAQ) to 51 women with fibromyalgia. As well as sociodemographic characteristics, the severity of relevant clinical symptoms, e.g., pain intensity, fatigue, and sleep disturbance, were assessed by visual analog scales. A tender point score (TPS) was calculated from tender points conducted by thumb palpation. Test-retest reliability, internal consistency, and concurrent and construct validities of FIQ were evaluated. Test-retest reliability and internal consistency were good at 0.81 and 0.72, respectively. Correlation between FIQ and HAQ scores was 0.43, which was low but statistically significant. Significant moderate correlations were obtained between the FIQ items and severity of clinical symptoms (0.63-0.77), except TPS, 0.31. The FIQ is a reliable and valid instrument for measuring functional disability in Turkish female FM patients.

Background Currently, no validated instruments are available to measure the health status of Bangladeshi patients with fibromyalgia (FM). The aims of this study were to cross-culturally adapt the modified Fibromyalgia Impact Questionnaire (FIQ) into Bengali (B-FIQ) and to test its validity and reliability in Bangladeshi patients with FM. Methods The FIQ was translated following cross-cultural adaptation guidelines and pretested in 30 female patients with FM. Next, the adapted B-FIQ was physician-administered to 102 consecutive female FM patients together with the Health Assessment Questionnaire (HAQ), selected subscales of the SF-36, and visual analog scales for current clinical symptoms. A tender point count (TPC) was performed by an experienced rheumatologist. Forty randomly selected patients completed the B-FIQ again after 7 days. Two control groups of 50 healthy people and 50 rheumatoid arthritis (RA) patients also completed the B-FIQ. Results For the final B-FIQ, five physical function sub-items were replaced with culturally appropriate equivalents. Internal consistency was adequate for both the 11-item physical function subscale (α = 0.73) and the total scale (α = 0.83). With exception of the physical function subscale, expected correlations were generally observed between the B-FIQ items and selected subscales of the SF-36, HAQ, clinical symptoms, and TPC. The B-FIQ was able to discriminate between FM patients and healthy controls and between FM patients and RA patients. Test-retest reliability was adequate for the physical function subscale (r = 0.86) and individual items (r = 0.73-0.86), except anxiety (r = 0.27) and morning tiredness (r = 0.64). Conclusion This study supports the reliability and validity of the B-FIQ as a measure of functional disability and health status in Bangladeshi women with FM.

The objective of this study was to analyze the genotype distributions and allele frequencies for the MAO-A and MAO-B polymorphism of the MAO gene among the patients with fibromyalgia syndrome (FS). One hundred and seven fibromyalgia patients and 90 unrelated healthy subjects were included into the study. Genomic DNA of 107 FS patients and 90 healthy control subjects were analyzed by polymerase chain reaction. Polymorphism of the MAO gene was: 1–1, 1–3, 3–3, 3–4. The “allele 3” had a 2.7 to 4.8-fold increased transcription activity than the “allele 1”. The frequencies of the genotypes of the patients with FS and healthy controls were compared. Although no significant difference was found in genotypes of patients and controls ( P  = 0.0559), it is likely that “allele 3” could be a more riskful factor for FS than “allele 1” ( P  = 0.033). Fibromyalgia impact questionnaire was administered to FS group as well as control group. One of our findings is that, the patients whose genotype 3–3 may be mostly affected by the symptoms of FS. In conclusion, it seems plausible to say that MAOA-dependent metabolism of the biological amines may be partly related to high-activated MAO-A, allele 3, in the occurrence of FS among Turkish population.